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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00996099
Other study ID # CGM-eMPC
Secondary ID
Status Completed
Phase N/A
First received October 15, 2009
Last updated October 15, 2009
Start date September 2008

Study information

Verified date October 2009
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority Czech Republic: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- elective cardiac surgery

Exclusion Criteria:

- insulin allergy

- mental incapacity

- language barrier

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment
Glucose measured with a real-time continuous glucose monitoring system served as an input for the enhanced model predictive control algorithm adjusting insulin infusion every 15 minutes for the first 24 hours after elective cardiac surgery
Other:
Intensive insulin therapy using standard protocol
Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.

Locations

Country Name City State
Czech Republic General University Hospital Prague

Sponsors (1)

Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters) first 24 hours after cardiac surgery Yes
Secondary Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range first 24 hours after cardiac surgery No
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